Indian Patent Office Retains Enhanced Efficacy Requirement in Examination Guidelines for Pharmaceutical Patents

摘要

The Indian Patent Office on Aug. 12 published a revised "Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals" after months-long consultations with stakeholders, retaining the contentious provisions on inventions not patentable, despite objections from drug makers and business associations.The earlier draft, released in February (see "India Proposes Inclusion of Enhanced Efficacy in Drug Patents Guidance" [28 WIPR 14, 4/1/14]) had suggested that a patent would be allowed on a new form of an existing drug only if the new drug has been shown to provide "enhanced therapeutic efficacy", a provision enshrined under section 3(d) of the Indian Patent Act of 1970.